# OMEPRAZOLE AND SODIUM BICARBONATE
> **ANDA204923** · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2016-11-07
## Drug
- **FDA Application Number:** ANDA204923
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** OMEPRAZOLE AND SODIUM BICARBONATE
- **Generic name:** OMEPRAZOLE AND SODIUM BICARBONATE
- **Active ingredients:** OMEPRAZOLE; SODIUM BICARBONATE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** AUROBINDO PHARMA
- **Manufacturer:** Aurohealth LLC
- **First approval:** 2016-11-07
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204923)
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